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Completed

NCT Number: NCT02074657

"LANK-2": Activated and Expanded NK Cell Immunotherapy Together With Salvage Chemotherapy in Children, Adolescents and Young Adults With Relapsed or Refractary Acute Leukemia

To determine safety profile of immunotherapy with natural killer cells and activated expanded (NKAEs) after salvage chemotherapy in children, adolescents and young adults with relapsed or refractary acute leukemia

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Key information

Conditions

Relapsed/Refractory Paediatric Acute Leukaemia Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

Up to 23 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital 12 de Octubre, Madrid, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients between 0 and 23 years of age with diagnosis of acute lymphoblastic leukemia, in second relapse situation, posttransplant relapse or refractary, or
  • Patients between 0 and 23 years of age with diagnosis of acute myeloblastic leukemia, relapsed or refractary. (Patient must meet inclusion criteria 1 or 2)
  • Lansky index > 60%
  • Mild (<2) functional organs alteration (hepatic, renal, respiratory) according to National Cancer Institute criteria (NCI CTCAE v4).
  • Left ventricular ejection fraction > 39%
  • To grant informed consent in accordance with the current legal regulations.
  • Presence of a compatible haploidentical donor (father or mother or brother).

Exclusion criteria

  • Patients with history of bad therapeutical compliance
  • Patients not valid after psycho-social evaluation
  • Positive HIV serology

Treatment and study plan

Activated and expanded natural killer cells (NKAEs)

Biological

Activated and expanded natural killer cells (NKAEs) from haploidentical donor

Primary outcomes

  1. To assess the safety of activated and expanded NK cell (NKAE) immunotherapy after salvage chemotherapy in patients with relapsed or refractary acute leukemia

    Time frame: 2 months after infusion

    Number of patients with adverse events according to NCI-CTCAE v4.0 CRITERIA as a measure of safety and tolerability

Secondary outcomes

  1. Incidence of episodes of febrile neutropenia, bacteriemia or viral or fungal infections

    Time frame: End of infusion and follow-up (2 months and 1 year)

  2. Days of hematological recovery (neutrophils >500/microL, lymphocytes >250/microL and platelets >50.000/microL), days of hospitalization, in each cycle Immune

    Time frame: End of infusion and follow-up (2 months and 1 year)

  3. Objective response rate according to cytomorphic and by "minimal residual disease" criteria (cytometry and/or real time PCR) at the end of the treatment

    Time frame: End of infusion and follow-up (2 months and 1 year)

  4. Immune reconstitution: Median of T-cell , B, NK, Natural Killer T cell (NKT) and dendritic cells count and subpopulations of T and NK lymphocytes (cel/microL) during posttreatment follow-up period.

    Time frame: End of infusion and follow-up (2 months and 1 year)

Sponsors and collaborators

Lead sponsor

Hospital Universitario La Paz

Other

Registry information

Acronym: LYDIA

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 28, 2014
Registry last updated
Dec 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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